Tempalgin^® (Tablets) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Dosage Form

Tempalgin®

Film-coated tablets, 500 mg+20 mg: 20 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets green in color, round, biconvex; the cross-section is almost white.

Excipients: wheat starch – 95 mg, microcrystalline cellulose – 75 mg, povidone K25 – 45 mg, talc – 15 mg, magnesium stearate – 10 mg.

Film coating composition Opadry II green 85F21526 – 23 mg (partially hydrolyzed polyvinyl alcohol – 9.2 mg, macrogol 3350 – 4.646 mg, titanium dioxide (E171) – 4.37 mg, talc – 3.404 mg, quinoline yellow (E104) aluminum lake – 1.035 mg, brilliant blue (E133) FCF aluminum lake – 0.345 mg).

10 pcs. – blisters (2) – cartons.
10 pcs. – blisters (10) – cartons.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Combined analgesic agent (non-narcotic analgesic agent + anxiolytic agent)

Pharmacological Action

Analgesic-antipyretic of combined composition. It has analgesic, antipyretic, weakly expressed anti-inflammatory and sedative effects. The drug contains the non-opioid analgesic metamizole sodium and the anxiolytic (tranquilizer) tempidone.

Pharmacokinetics

Data on the pharmacokinetics of the drug Tempalgin^® are not provided.

Indications

• Moderate or mild pain syndrome (including headache, migraine, toothache, neuralgia, radicular syndrome, myalgia, arthralgia, dysmenorrhea), especially in patients with increased nervous excitability;
• Mild pain of visceral origin (including renal, hepatic, intestinal colic) in combination with antispasmodic therapy;
• Pain syndrome after surgical and diagnostic interventions (as an auxiliary agent);
• Increased body temperature in colds and other infectious and inflammatory diseases.

ICD codes

Dosage Regimen

The tablets are taken orally, without chewing, with a sufficient amount of liquid, during or after meals.

Adults are prescribed 1 tablet 1-3 times/day; if the effect is insufficient, an additional 1 tablet can be taken. The maximum single dose is 2 tablets, the maximum daily dose is 6 tablets. The duration of administration should not exceed 5 days. An increase in the daily dose or an extension of the treatment duration is possible only under medical supervision.

Adverse Reactions

From the digestive system rarely – burning sensation in the epigastric region, dry mouth, cholestasis, jaundice, increased activity of liver transaminases, hyperbilirubinemia.

From the CNS headache, dizziness; in some cases – hallucinations.

From the cardiovascular system decrease or increase in blood pressure, tachycardia, cyanosis.

From the hematopoietic system agranulocytosis, leukopenia, thrombocytopenia.

From the urinary system when used in high doses – impaired renal function (oliguria, anuria, proteinuria, interstitial nephritis); red coloration of urine.

Allergic reactions skin rash, itching, urticaria (including on the conjunctiva and on the mucous membranes of the nasopharynx), angioedema, multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospasm, anaphylactic shock.

Contraindications

• Severe hepatic insufficiency;
• Severe renal insufficiency;
• Chronic heart failure;
• Arterial hypotension (decrease in systolic blood pressure below 100 mm Hg);
• Hematopoiesis depression (granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia);
• Glucose-6-phosphate dehydrogenase deficiency;
• "aspirin" asthma;
• Pregnancy;
• Lactation period (breastfeeding);
• Childhood (up to 14 years);
• Hypersensitivity to metamizole sodium, pyrazolone derivatives or triacetonamine-4-toluenesulfonate.

Use with caution in kidney diseases (pyelonephritis, glomerulonephritis, including in history), moderate hepatic/renal insufficiency, in bronchial asthma, predisposition to the development of arterial hypotension, with long-term alcohol abuse.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy. The drug should not be used during lactation, as both components are excreted in breast milk.

Use in Hepatic Impairment

Contraindicated in severe liver function disorders.

Use in Renal Impairment

Contraindicated in severe renal function disorders.

Special Precautions

Radiocontrast agents, colloidal blood substitutes and penicillin should not be prescribed when using Metamizole sodium.

Alcohol should not be consumed during the drug intake.

The use of the drug in patients receiving cytostatics should be carried out only under medical supervision.

Against the background of the use of Metamizole sodium, the development of agranulocytosis is possible, in connection with which, if an unclear genesis of fever, chills, sore throat, difficulty swallowing, stomatitis is detected, as well as with the development of vaginitis or proctitis, the drug should be discontinued.

With long-term (more than 7 days) use of the drug, monitoring of the blood picture and functional state of the liver is necessary.

The use of Tempalgin^® for the relief of acute abdominal pain (until the cause is clarified) is unacceptable.

Influence on the ability to drive vehicles and mechanisms

Due to the anxiolytic effect of the drug, during the intake of Tempalgin^®, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms nausea, vomiting, epigastric pain, oliguria, tachycardia, decreased blood pressure, shortness of breath, tinnitus, drowsiness, impaired consciousness, convulsions.

Treatment gastric lavage, administration of saline laxatives and activated charcoal; in severe cases – hemodialysis, forced diuresis, symptomatic therapy, with the development of convulsive syndrome – intravenous administration of diazepam and fast-acting barbiturates.

Drug Interactions

Tempalgin^® enhances the effects of ethanol.

Simultaneous use of Tempalgin^® with chlorpromazine or other phenothiazine derivatives may lead to the development of severe hyperthermia.

Sedatives and tranquilizers enhance the analgesic effect of the drug.

With simultaneous use, thiamazole and cytostatics increase the risk of leukopenia.

With simultaneous use of Metamizole sodium with cyclosporine, the concentration of the latter in blood plasma decreases.

Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, corticosteroids and indomethacin from protein binding, increases their effect.

With simultaneous use, barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of Metamizole sodium.

Simultaneous use of Metamizole sodium with other non-opioid analgesics, tricyclic antidepressants, oral contraceptives, allopurinol may lead to mutual enhancement of toxic effects.

Codeine, histamine H₂-receptor blockers and propranolol slow down the excretion of Metamizole sodium and enhance its effect.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.